Baxter recalls specific hemostatic matrix products due to inaccurate marketing brochures that don't match product instructions. Affected units include certain product codes and serial numbers.
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Baxter is recalling specific hemostatic matrix products because their marketing brochures contain inaccurate information that doesn't match the product's instructions for use or prescribing information. This could lead to incorrect usage if healthcare providers rely on the outdated brochure content.
The marketing brochures distributed with these products have inaccurate content that doesn't align with the product's current Instructions for Use or Prescribing Information. This mismatch could lead to incorrect usage if healthcare providers rely on the outdated brochure information instead of the updated product guidelines.
Healthcare providers using Baxter FloSeal Hemostatic Matrix RECOTHROM products with the specified product codes and serial numbers are most at risk. The recall affects medical professionals who follow the outdated marketing brochures instead of current instructions.
Check for product codes: ADS202105 (5mL-6 PK US) or ADS202110 (10mL US). Look for serial numbers: 85412827957 for ADS202105 or 85412827896 for ADS202110.
Verify your product code and serial number against the listed codes and serial numbers to confirm if it's affected.
The marketing brochures distributed with these products contain inaccurate content that doesn't align with the product's current Instructions for Use or Prescribing Information.
The recall does not require immediate action; check your product details to see if it's affected. If it is, you may need to follow updated instructions instead of the outdated brochure content.
The recall is due to inaccurate marketing brochures, not a safety hazard. There is no risk of injury or harm from using the product correctly as per current instructions.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0662-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0662-2024 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
